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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAK | Other Identifier | Eli Lilly and Company | |
| 2025-523873-41-00 | EU Trial (CTIS) Number |
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The main purpose of the study is to measure and compare the effects of eloralintide and placebo on insulin sensitivity (how your body responds to insulin), metabolic health (things like sugar and cholesterol), and body weight in participants with obesity or overweight. For each participant, the study will last about 35 weeks and include 3 in patient visits totaling 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide | Experimental | Eloralintide administered subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eloralintide | Drug | Eloralintide administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Hyperinsulinemic Euglycemic Clamp (HEC) Predicted Clamp-Derived Insulin Sensitivity (M-value) | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Body Weight | Baseline, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Have type 1 or type 2 diabetes mellitus, a history of ketoacidosis, or of hyperosmolar state or coma. Note: Participants with a history of gestational diabetes are eligible to participate in this study.
Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.
Have a known clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal (GI) motility to a significant extent.
Have a prior or planned surgical treatment for obesity. Exceptions: The following are allowed if they occurred more than 1 year before screening:
Are unwilling to comply with the lifestyle and dietary restrictions required for this study.
Are individuals AFAB who are lactating.
Are individuals AFAB who are pregnant or intend to become pregnant or to breastfeed during the study, or individuals AMAB who intend to conceive a pregnancy during the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | 41460 | Germany |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Other | Placebo administered SC |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |